European Journal of Preventive Cardiology CONSENSUS DOCUMENT doi:10.1093/eurjpc/zwaa121 Cardiac rehabilitation

Comprehensive multicomponent cardiac

rehabilitation in cardiac implantable electronic Downloaded from https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaa121/6119672 by guest on 21 February 2021 devices recipients: a consensus document from the European Association of Preventive Cardiology (EAPC; Secondary prevention and rehabilitation section) and European Heart Rhythm Association (EHRA)

Roberto F.E. Pedretti 1*, Marie-Christine Iliou2, Carsten W. Israel3, Ana Abreu4, Hielko Miljoen 5, Ugo Corra` 6, Christoph Stellbrink7, Andreas B. Gevaert5, Dominic A. Theuns8, Massimo F. Piepoli9, Rona Reibis10,11, Jean Paul Schmid12, Matthias Wilhelm13, Hein Heidbuchel5†, and Heinz Vo¨ller14,15† Document reviewers: Marco Ambrosetti16, Thomas Deneke17, Veronique Cornelissen18, Frank R. Heinzel19,20, Constantinos H. Davos21, Gulmira Kudaiberdieva22, Ines Frederix23,24,25,26, Jesper Hastrup Svendsen27,28, and Dominique Hansen29,30

1Cardiovascular Department, IRCCS MultiMedica, Care and Research Institute, Via Milanese 300, Sesto San Giovanni, Milano 20099, Italy; 2Department of Cardiac Rehabilitation and Secondary Prevention, Hoˆpital Corentin Celton, Assistance Pulique Hopitaux de Paris centre-Universite de Paris, France; 3Department of Cardiology, Bethel Clinic, J.W. Goethe University, Frankfurt, Germany; 4Servico de Cardiologia, Hospital Universita´rio de Santa Maria/Centro Hospitalar Universita´rio Lisboa Norte (CHULN), Centro Academico de Medicina de Lisboa (CAML), Centro Cardiovascular da Universidade de Lisboa (CCUL), Faculdade de Medicina, Universidade de Lisboa, Portugal; 5Department of Cardiology, University of Antwerp and University Hospital Antwerp, and Antwerp University, Antwerp, Belgium; 6Department of Cardiac Rehabilitation, ICS Maugeri Care and Research Institute, Veruno, Novara, Italy; 7Department of Cardiology and Intensive Care Medicine, Klinikum Bielefeld GmbH, Bielefeld, Germany; 8Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands; 9Heart Failure Unit, G. da Saliceto Hospital, AUSL Piacenza and University of Parma, Parma, Italy; 10Department of Rehabilitation Medicine, Faculty of Health Sciences Brandenburg, University of Potsdam, Potsdam, Germany; 11Cardiac Outpatient Clinic Am Park Sanssouci, Potsdam, Germany; 12Department of Cardiology, Clinic Barmelweid, Erlinsbach, Switzerland; 13Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; 14Department of Rehabilitation Medicine, Faculty of Health Sciences Brandenburg, University of Potsdam, Potsdam, Germany; 15Klinik am See, Rehabilitation Centre for Internal Medicine, Ru¨dersdorf, Germany; 16Cardiovascular Rehabilitation Unit, ASST Crema, Santa Marta Hospital, Rivolta d’Adda, Italy; 17Heart Center Rho¨n-Klinikum Campus Bad Neustadt, Bad Neustadt, Germany; 18Cardiovascular Exercise Physiology Unit, Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium; 19Department of Cardiology, Charite´— Universitaetsmedizin Berlin, Campus Virchow-Klinikum, Berlin, Germany; 20Berlin Institute of Health, Berlin, Germany; 21Cardiovascular Research Laboratory, Biomedical Research Foundation, Academy of Athens, Athens, Greece; 22SRI of Heart Surgery and Organ Transplantation, Center Scientific Research and Development of Education, Bishkek Kyrgyzstan, Adana, Turkey; 23Hasselt University, Faculty of Medicine & Life Sciences, Hasselt, Belgium; 24Antwerp University, Faculty of Medicine & Health Sciences, Antwerp, Belgium; 25Department of Cardiology, Jessa Hospital, Hasselt, Belgium; 26Intensive Care Unit, Antwerp University Hospital, Edegem, Belgium; 27Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; 28Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; 29Heart Centre Hasselt, Jessa Hospital, Hasselt, Belgium; and 30Faculty of Medicine and Life Sciences, UHasselt, BIOMED-REVAL-Rehabilitation Research Centre, Hasselt University, Hasselt, Belgium

Received 14 September 2020; revised 25 October 2020; editorial decision 28 October 2020; accepted 2 November 2020

Cardiac rehabilitation (CR) is a multidisciplinary intervention including patient assessment and medical actions to promote stabilization, management of cardiovascular risk factors, vocational support, psychosocial management, physical activity counselling, and prescription of

* Corresponding author. Tel: þ39 02 24209590, Email: [email protected] † These authors shared last authorship. Published on behalf of the European Society of Cardiology. All rights reserved. VC The Author(s) 2021. For permissions, please email: [email protected]. 2 R.F.E. Pedretti et al.

exercise training. Millions of people with cardiac implantable electronic devices live in Europe and their numbers are progressively increas- ing, therefore, large subsets of patients admitted in CR facilities have a cardiac implantable electronic device. Patients who are cardiac implantable electronic devices recipients are considered eligible for a CR programme. This is not only related to the underlying heart disease but also to specific issues, such as psychological adaptation to living with an implanted device and, in implantable cardioverter-defibrillator patients, the risk of arrhythmia, syncope, and sudden cardiac death. Therefore, these patients should receive spe- cial attention, as their needs may differ from other patients participating in CR. As evidence from studies of CR in patients with cardiac implantable electronic devices is sparse, detailed clinical practice guidelines are lacking. Here, we aim to provide practical recommenda-

tions for CR in cardiac implantable electronic devices recipients in order to increase CR implementation, efficacy, and safety in this subset Downloaded from https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaa121/6119672 by guest on 21 February 2021 of patients...... Keywords Cardiac rehabilitation • Cardiac implantable electronic devices • Pacemaker • Implantable cardioverter- defibrillator • Cardiac resynchronization therapy • Prevention • Exercise training • Heart failure • Physical activity

. . of life (QoL), and increasing survival. Exercise training is a key compo- Why should the heterogeneous . . nent of a CR programme: together with CIED functions like rate sta- group of cardiac implantable . bilization, chronotropic support, and resynchronization, it may . 3 electronic device recipients . provide a significant synergistic effect on heart function. . In ICD recipients, fear of shocks often leads to fear of exercise and perform cardiac rehabilitation? . . self-limitation of everyday activities. In addition, referral from hospi- . tals to CR centres is often negatively impacted by the fear of inappro- Cardiac rehabilitation (CR) is a multidisciplinary intervention, which is . recognized as integral to the comprehensive care of cardiac patients.1 . priate shock delivery during exercise. These aspects can therefore . deprive ICD recipients of the well-established beneficial effects of CR Core components of CR include patient assessment and medical . actions to promote stabilization, management of cardiovascular risk . in terms of secondary prevention, physiological, and psychosocial . factors, vocational support, psychosocial management, physical activ- . functioning. . As evidence from studies of CR in patients with CIED is sparse, ity counselling, and prescription of exercise training (ET). . Currently, millions of people with cardiac implantable electronic . detailed clinical practice guidelines are lacking. Here, we aim to pro- . vide practical recommendations for CR in CIED recipients in order device (CIED) live in Europe and hundreds of thousands join them . every year: according to a 2017 report of the European Heart . to increase CR implementation, efficacy, and safety in this subset of . patients. Rhythm Association (EHRA), a total of 547 586 pacemakers (PMs), . 105 730 implantable cardioverter-defibrillators (ICDs), and 87 654 . . cardiac resynchronization therapy (CRT) devices were implanted in . 2 . Summary box 1 the ESC area in 2016. . . • Hence, large subsets of patients participating in CR programmes . Patients who are CIED recipients are considered eligible for have a PM, CRT, or ICD. Cardiac rehabilitation for patients with . a CR programme. This is not only related to the underlying . heart disease but also to specific issues, such as psychological CIED is a unique opportunity not only to optimize medical treatment, . to increase exercise capacity, and to improve their clinical condition . adaptation to living with an implanted device and, in ICD . patients, the risk of arrhythmia, syncope, and sudden cardiac but also to supervise the correct functioning of the device. . . death. Therefore, these patients should receive special atten- Patients who are CIED recipients are considered eligible for a CR . . tion, as their needs may differ from other patients participat- 1 . programme. This is not only related to the underlying heart disease . ing in CR. but also to specific issues, such as psychological adaptation to living . . • The present paper is aimed to provide practical recommen- with an implanted device and, in ICD patients, the risk of arrhythmia, . dations for CR in CIED recipients in order to increase CR . syncope, and sudden cardiac death. Therefore, these patients should . implementation, efficacy, and safety in this subset of patients. receive special attention, as their needs may differ from other . . patients participating in CR. . Patients with CIEDs, as the other cardiac patients who are poten- . . tially eligible for CR, may have barriers that limit their participation, . 1 . patient- or system-related. It should be noted, however, that nearly . Clinical and technical evaluation 1 . all patients with CVD, including those with CIEDs, could benefit . . in cardiac implantable electronic from at least some components of a CR programme. . Cardiac implantable electronic devices are usually programmed at . devices recipients presenting for . rest but their assessment during exercise may provide important clin- . cardiac rehabilitation ical information, particularly in, those patients with chronotropic in- . . competence or in those with rate response programming devices. . The history of the CIED implantation should be investigated: indica- Stimulation therapy is aimed at reducing symptoms, improving quality . tion for the implantation, including the index event, and underlying Cardiac Rehab in cardiac implantable electronic devices recipients 3

. heart disease. Also, comorbidities that may complicate ET or might . A symptom-limited exercise test, preferably a cardiopulmonary impose an additional risk should be described.4 . exercise test (CPET), should be performed before the start of a CR . Symptoms should be sought after, particularly sudden onset of diz- . and ET programme, also for safety and reassurance of patient and ziness or fatigue during exercise. Syncope and palpitations could be a . physician.1,16 Enabling device telemetry during the exercise test . sign of malcapture or uncontrolled arrhythmia. Hiccups (suggestive . allows simultaneous recording of surface ECG, marker annotations, of phrenic nerve stimulation) should be specifically addressed. . and intracardiac electrograms, which can provide additional . The patient’s mental status also deserves attention: psychological . information. stress is a known predictor of worse outcomes in CIED patients.5,6 . Analysis of standard CPET parameters (peak oxygen uptake

. Downloaded from https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaa121/6119672 by guest on 21 February 2021 ICD-specific measures, evaluating shock anxiety, device acceptance, . [VO ], ventilatory thresholds, O pulse, VE/VCO slope) in . 2 2 2 behavioural avoidance, and ICD-specific patient concerns are . patients with a CIED is not different than in other patients with car- 5 . 17–20 available. . diovascular disease and has been reviewed elsewhere. The physical examination includes a standard cardiovascular as- . Nevertheless, a CPET in CIED recipients provides a unique oppor- . sessment. Additionally, device position, signs of potential infection . tunity to test device settings and the evaluation of exercise re- (redness, hotness, and pain), and presence of arm oedema or collat- . sponse allows to establish some crucial points, apart from . 21 eral circulation suggestive of central vein stenosis should be . ischaemia and exercise capacity : evaluated.7 . . (1) heart rate at rest, chronotropic response to exercise and during An ECG at rest and during exercise testing shows the device at . . recovery; work. This can help to fine-tune the settings to prevent undesired . (2) presence of exercise-induced arrhythmias; 8,9 . pacing or to initiate optimization of a CRT device in the absence of . (3) HR in case of onset of arrhythmia; 10 . a narrowing of the QRS, or in the case of pseudofusion pacing. . (4) effectiveness of pharmacological HR control; Device interrogation in CR is not different from what is generally . . (5) risk of reaching an exercise HR in the ICD intervention zone; and performed (settings, sensing, pacing threshold, impedance, battery . (6) evaluation of maximum tracking rate and continuous biventricular . stimulation. longevity, and arrhythmia log) since, during CR, some challenges may . arise (Table 1). Characteristics of an appropriate programming of . . First, not only the HR response to exercise should be evaluated. CIED during a CR programme are reported in the sections below; . . Optimally, if ventricular pacing is needed or desired, the PM should however, it is important to mention here that both the patient and . . be programmed to at least track the maximum sinus rate reached the CR team need to be aware of device settings, especially the rate . during exercise. A different matter is rate response: there is still 11 . cut-off for therapy in patients with defibrillator. Patients should be . 22–24 . much controversy on its effectiveness, especially in HF patients. instructed to keep the heart rate (HR) at least 10–20 b.p.m. below . As no deleterious effects have been described, this feature can prob- 4 . the rate cut-off during exercise (see below, ‘Safety issues’). . ably be programmed ‘ON’ safely. Cardiopulmonary exercise test can Another important observation is pacing percentage, dependent . . be used to optimize rate response [and rate-adaptive atrioventricular . 25 on the type of CIED. In patients with a PM or an ICD, a right ventricu- . (AV)-delay] by the device. Of note, cyclergometer-based rate re- lar pacing percentage near 0% is desirable12,13 owing to its unfavour- . . sponse may not always be indicative of rate response during other able effects on regional myocardial perfusion, myocardial . . forms of exercise. Treadmill exercise testing should be preferentially metabolism, and contraction synchronism. Negative effects of right . used in patients with rate response programming devices since exer- ventricular pacing are particularly evident in patients with preserved . . cise on a treadmill is closer to physical activity performed during daily ejection fraction heart failure (HF) or asymptomatic left ventricular . life. dysfunction. In CRT recipients, a percentage near 100% is aimed for, . . In CRT, the exercise ECG allows to evaluate the delivery of actual as the percentage of ventricular pacing correlates strongly with sur- . resynchronization and its persistence during exercise, based on the 14,15 . vival and morbidity. Rate response histograms need to be ana- . 10 . QRS morphology. lysed for frequency distribution. . Of final note, in patients with continuous ventricular pacing, the . . evaluation of exercise-induced ischaemia based on the ECG is im- . possible and cardiac memory may be a source of repolarization Table 1 Challenges in patients with cardiac implant- . able electronic device during cardiac rehabilitation . abnormalities in those patients with discontinuous pacing. Other . modalities may be needed,9 and cardiac imaging techniques are . Chronotropic incompetence, inappropriate sensor function for . recommended to evaluate the presence and extension of myocar- rate-adaptive pacing (under- or overresponsive). . 26 . dial ischaemia ; nevertheless, gas analysis can detect myocardial is- Sinus tachycardia above the upper tracking limit (dual-chamber and . chaemia during exercise with reduced pulse volume and cardiac CRT devices). . . out-put before the development of ST-segment changes or chest Under- and oversensing (pacemaker and ICD). . pain.27 Arrhythmias (ventricular or supraventricular extrabeats, junctional . . During follow-up of CIED patients, a chest X-ray can be useful to rhythm, supraventricular, and ventricular tachyarrhythmias). . detect lead fracture, dislocation, or perforation if the electrical pacing Changes in AV conduction. . . parameters (threshold, impedance, and sensing) have changed. Lead . perforation may be better detected with computed tomography.28 AV, atrioventricular; CRT, cardiac resynchronization therapy; ICD, implantable . cardioverter-defibrillator. . Before starting CR, a recent echocardiogram should be available . to evaluate cardiac structure and function. Presence of low left 4 R.F.E. Pedretti et al.

. ventricular ejection fraction (LVEF), elevated left ventricular filling . . Table 2 Key points in the clinical and technical evalu- pressures, pulmonary artery pressures, or congestion require further . ation of patients with cardiac implantable electronic de- investigation.4 The tricuspid valve deserves special focus, as implant- . . vice in the setting of cardiac rehabilitation ation of a right ventricular lead may induce or aggravate tricuspid re- . gurgitation, especially if atrial fibrillation is present.29 . History . In CRT, routine echocardiographic AV and interventricular opti- . Disease tolerance: physical complaints (angina, palpitations, (pre)- mization are not recommended.9,10 However, it can be of benefit in . syncope, psychological coping with being a ‘cardiac patient’) . CRT non-responders.30 Exercise itself may alter ventricular syn- . Exercise intolerance, with special attention to sudden decrease in

. Downloaded from https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaa121/6119672 by guest on 21 February 2021 . exercise capacity (suggestive of ischaemia, sudden onset of conduc- chrony, but only limited data exist on optimizing CRT during exer- . cise.31,32 Again, this may provide an additional tool in non- . tion disturbances, or arrhythmias) . Comorbidities that may interfere with exercise training responders, whether performed during CPET or during exercise . echocardiography. . Device tolerance: physical discomfort, phrenic nerve stimulation, . and psychological coping Although modern CIEDs have an in-built Holter providing arrhyth- . mia detection and summaries of pacing percentages, there is still a . Clinical examination . Device position and aspect of pocket use for Holter monitoring, especially in the context of unexplained . . Presence of arm oedema, collateral circulation (suggestive of sub- symptoms.33 . . clavian thrombosis) Chronotropic response or chronotropic (in)competence during . . BP control everyday life can be evaluated with a 24-h Holter, potentially prompt- . . ECG ing adjustments to device settings. . . Non-paced/inhibited In CRT, the device-declared percentage pacing can overestimate . . Underlying rhythm the percentage of effective resynchronization, especially in atrial fibril- . 34 . Resting HR lation. Holter monitoring can help to objectivize this, facilitating op- . 34,35 . Intrinsic conduction (PR interval) timization of device settings. Some companies have built-in . 36 . Device settings algorithms to address this issue. . . Capture and sensing . Arrhythmias . Summary box 2 . Effectiveness of CRT . Device interrogation • Clinical and laboratory evaluation is the first step in evaluating . . Algorithms to minimize ventricular pacing CIED patients in the setting of comprehensive CR. Minimally, . . Rate responsiveness/sensor programming history and clinical examination, device interrogation, chest . X-ray, echocardiogram, CPET, and Holter should be per- . Automatic CRT-optimization algorithms . In ICD: arrhythmia detection cut-offs formed before starting exercise-based CR. Key points are . summarized in Table 2. . Exercise test, preferably CPET . Upper rate behaviour . . Chronotropic competence or appropriateness of rate response . Exercise induced tachyarrhythmias, conduction disturbances . Specificities of a comprehensive . including rate dependent branch block . Appropriate AV interval adaptation to ensure resynchronization . cardiac rehabilitation programme . Imaging . Chest X-ray in specific cardiac implantable . . Lead position(s) electronic devices recipients . Complications (lead fracture, dislocation, perforation) . . Echocardiography Implantable cardioverter-defibrillator . . Left ventricular ejection fraction ICD patients still have low referral rates and poor adherence to CR. . Lead related tricuspid regurgitation This observation might be attributed to the high incidence of anxiety . . Exercise echocardiography: evaluation of exercise induced dys- and depression (18–38% and 28–32%, respectively) and to the fear of . synchony with CRT optimization 37 . ICD discharges, highlighting the importance of psychoeducational . Holter monitoring component of CR. . . Chronotropic competence or appropriateness of rate response Patients with ICD are recommended to participate in a CR pro- . Occurrence of arrhythmias undetected by CIED 21 . gramme in the context of : . Effectiveness of pacing in CRT . (1) primary cardiac disease multidisciplinary management, including . . CIED, cardiac implantable electronic device; CPET, cardiopulmonary exercise medical treatments, cardiovascular risk factors control, return to . test; CRT, cardiac resynchronization therapy; ECG, electrocardiogram; HR, heart work; and . rate; ICD, implantable cardioverter-defibrillator; MRI, magnetic resonance . imaging. (2) after ICD implantation in primary arrhythmogenic cardiopathies, . mostly for exercise, physical activity, and psychoeducational . components. . Cardiac Rehab in cardiac implantable electronic devices recipients 5

. Centre-based, with professional supervision and individualized . As most CRT recipients are HFrEF patients, it is suggested that the monitoring, as well as home-based CR, allow these patients to im- . exercise prescription may follow guidelines suggested for people 21,38 . 44,45 prove their exercise capacity safely. If both centre-based and . with HFrEF, with specific adaptations. home-based CR programmes are available, centre-based CR could . The CRT population includes individuals with a CRT-P or a CRT-D . be recommended early after implantation, then home-based CR . device, and specificities reported for ICD recipients should be taken could definitively be an option. A multidisciplinary team directed by a . into account for those who have an implanted CRT-D. The program- . cardiologist with competence in secondary prevention and CR has to . ming parameters of the CRT device in terms of AV delay and opti- be involved in the care of CIED recipients.1 Among consultant pro- . mization protocols may contribute significantly to this therapy

. Downloaded from https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaa121/6119672 by guest on 21 February 2021 fessionals, an electrophysiologist should be available for consultation. . benefits and could improve exercise performance if standardized.46 . Strategies targeted to support an active lifestyle for individuals who . Some points need specific attention during ET in CRT recipients: receive an ICD shock before, during, or after exercise need to be . . (1) exercise can induce sinus tachycardia above upper tracking limit implemented, including psychological techniques to reduce fear and . . (UTL), causing inadequate tracking of sinus rhythm (PM anxiety and convincing individuals with ICD to undertake exercise. . Wenckebach or 2:1 block). This is particularly important in patients The risk of arrhythmias during exercise (ventricular and supraven- . with CRT, as device settings are optimized for 100% (biventricular) . tricular) might be increased by several factors: i.e. acute exercise by . pacing, also during exercise. This subject is described in detail in the an excessive adrenergic stimulation, myocardial ischaemia, or the . section below on programming of CIED during a CR programme. . presence of some specific underlying cardiac diseases (long QT syn- . (2) Exercise can induce changes in AV conduction leading to loss of drome, hypertrophic cardiomyopathy, arrhythmogenic right ven- . resynchronization. . (3) The CR team should pay attention to possible limiting factors asso- tricular cardiomyopathy, and catecholaminergic polymorphic . ventricular tachycardia (VT)).21 . ciated with pacing therapy. If the patient’s atrial rate is paced, then . the CR team should be especially mindful of a blunted or delayed The risks of severe ventricular arrhythmias [VT or ventricular fib- . . HR response to exercise. rillation [VF]) during exercise testing depend also on the underlying . cardiac disease and the previous history of VT/VF.21 Supraventricular . Daily activity at lower intensities should supplement the exercise . arrhythmias may trigger an inappropriate shock and should therefore . programme to sustain secondary prevention and morbidity benefits, be prevented.21 . per guideline recommendations.47 . In order to prevent inappropriate shocks, the following measures . 21 . are recommended : . . (1) stop the exercise testing and training 10–20 b.p.m. below the pro- . . Summary box 3 grammed zones of ICD therapies; . (2) continuously monitor CIED recipients during ET sessions, at least . ICD . during the first session at every increase of exercise intensity; and . • (3) use beta-blockers, when clinically indicated for the patient’s disease, . Centre-based, with professional supervision and individual- . ized monitoring, as well as home-based CR, allow ICD and monitor their effects on maximal HR. . . patients to improve their exercise capacity safely. . • Wearables, such as smartwatches and HR monitors, are recom- . The risks of severe ventricular arrhythmias during exercise mended to patients at home, during daily life, physical, and sport . testing depend of the underlying cardiac disease and the pre- . vious history of life-threatening ventricular arrhythmias. activities. . Theoretically, pronounced arm–shoulder movements or intense . Supraventricular arrhythmias may trigger an inappropriate . shock and should therefore be prevented mechanical strain of the ICD pouch could also trigger inappropriate . . • In order to prevent inappropriate shocks, the following ICD shocks, particularly in the case of subcutaneous-ICD,39 but in . . measures are recommended: giving advice, this should not be presented as a reason for patients to . . avoid exercise. . • stop the exercise testing and training 10–20 b.p.m. below The CR staff should be confident, expressing understanding of the . . the programmed zones of ICD therapies; purpose of the device and that this increases the safety of the patient. . • continuously monitor CIED recipients during ET sessions, In case of any device intervention (appropriate or inappropriate), the . at least during the first session at every increase of exer- . cardiologist should assess the causes, and any changes in device pro- . cise intensity; . • use beta-blockers and monitor their effects on maximal gramming, medications, or exercise regime should be considered. . Exercise should be started again swiftly after the device interrogation . HR; and . • wearables, such as smartwatches and HR monitors, are to avoid that the ICD discharge can become a psychological block of . . recommended to patients at home, during daily life, phys- future activity.21 . . ical, and sport activities. . Cardiac resynchronization therapy . . CRT In patients with reduced ejection fraction HF (HFrEF), CRT has been . . • shown to reduce symptoms, hospitalizations, and mortality, while . The CRT population includes individuals with a CRT-P or a 40–42 . CRT-D device, and specificities reported for ICD recipients increasing exercise capacity, cardiac performance, and QoL; . nevertheless in one-third of CRT recipients, a lack of symptoms im- . should be taken into account for those who have an 43 . implanted CRT-D. provement still remains. . 6 R.F.E. Pedretti et al.

• . exercise capacity, both in ICD and CRT patients.48 Most often ET The programming parameters of the CRT device in terms of . atrial ventricular delay and optimization protocols may con- . was prescribed supervised as single intervention or integrated in a . 49–60 tribute significantly to this therapy benefits and could im- . comprehensive CR programme. prove exercise performance if standardized. . In the largest supervised ET study in HFrEF patients (HF- • . Some points need specific attention during ET in CRT recipi- . ACTION), the relationship between outcomes and randomized ents: . . treatment according to ventricular pacing status was exam- . ined.51,61 Of 2331 patients, 1118 (48%) had an ICD: 683 with right • exercise can induce sinus tachycardia above UTL, causing . . ventricular and 435 with biventricular pacing.61 Patients with devi- inadequate tracking of sinus rhythm (PM Wenckebach or . Downloaded from https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaa121/6119672 by guest on 21 February 2021 . ces were older, and had a lower absolute peak VO ;ETsimilarly 2:1 block); . 2 • exercise can induce changes in AV conduction leading to . improved absolute peak VO2 in groups with and without pacing . 61 loss of resynchronization; and . devices. However, the primary composite endpoint (all-cause • the CR team should pay attention to possible limiting fac- . . death or hospitalization) was reduced only in patients randomized tors associated with pacing therapy. . to ET without a CIED.61 Therefore, the authors concluded that ET . . may improve exercise capacity in patients with implanted cardiac . devices, but the apparent beneficial effects of exercise on hospital- . Prescribing exercise training in . ization or death may be attenuated in patients with CIEDs, requir- . ing further study.61 . cardiac implantable electronic . In another study from HF-ACTION patients, a history of sustained . device recipients . VT/VF, previous atrial fibrillation/flutter, exercise-induced dysrhyth- . mia, lower diastolic blood pressure, and non-white race, but not ET, . 51 Different exercise protocols including moderate intensity continuous . were associated with an increased risk of ICD shocks. training, high-intensity interval training, resistance/strength training, . A recent systematic review and meta-analysis (1730 participants, 8 . or combinations of these modalities have been evaluated in CIED . trials, mean ET duration 12 weeks, and follow-up 8–24 weeks) patients (Table 3).46 Structured ET results in similar improvements in . showed that ICD patients, following exercise-based CR, achieved a

Table 3 Exercise training studies in cardiac implantable electronic device patients

Exercise type Studies Patients Setting Exercise training Outcome Safety characteristics ......

Moderate intensity N =7 HFrEF, NYHA II–IV Supervised exercise Frequency: 3–5 Delta VO2peak þ No more shocks continuous (2 ICD, 2 ICD and (N =6) training (N =5) times/week for 4.0–30% during exercise, training49–51,53,63,64 CRT, 3 CRT) ICD for prim. or Telemonitoring 8–16 weeks no severe ad- Exercise: 508 ICD, sec. prevention (N =2) Intensity: 60% peak verse events. 298 CRT of SCD (HFrEF VO2, 60–80% No data on safety Control: 418 ICD, 73%) (N =1) HRR, 90% VT1, (N =2) 281 CRT 80–90% peak HR Time: 5–120 min High-intensity inter- N =2 HFrEF, NYHA I–III Supervised exercise Frequency: 2–3 Delta peak No more shocks 52,55 val training (1 ICD, 1 CRT) training times/week for VO2 þ 3.7–9.8% during exercise, Exercise: 38 ICD, 34 2–24 weeks no severe ad- CRT Intensity: 4 min verse events Control: 12 ICD, 29 85–95% peak (N = 1). CRT HR, 3 min 60– No data on safety 70% peak HR (N = 1). Time: 60–75 min Moderate intensity N =5 HFrEF, NYHA I–IV Supervised exercise Frequency: 2–3/ Delta peak No more shocks

continuous and (4 ICD, 1 CRT) (N =2) training (N =1) week for VO2 þ 7.0–15% during exercise, resistance/ Exercise: 272 ICD, ICD for prim. or Comprehensive CR 2–24 weeks no severe ad- strength 223 CRT sec. prevention (N =4) Intensity: 50–90% verse events. training56–60 Control: 142 ICD, of SCD (HFrEF peak HR, 432 CRT, 515 no 24–73%) (N =3) 50–90% HRR, ICD 50–80% 1-RM Time: 30–90 min

1-RM, one repetition maximum; HFrEF, heart failure with reduced ejection fraction; HRR, heart rate reserve; SCD, sudden cardiac death; VT1, first ventilator threshold. Cardiac Rehab in cardiac implantable electronic devices recipients 7

. better exercise capacity. The impact on all-cause mortality, serious . attention is required with shoulder movement in order to avoid . adverse events, and health-related QoL remained unclear due to . important strain in the side of implant, particularly in the early small numbers of events and enrolled patients.62 . phase after device placement.72 Upper body strength training . Telemonitored ET in HFrEF was used in one study with ICD . may dislodge newly implanted leads, and therefore, resistance train- patients [New York Heart Association (NYHA) II–III, N = 111],63 and . ing is not recommended in the first 4–6 weeks post-implant. Any . in one study with CRT-D patients (NYHA III, N = 52, following a . activities that could result in a direct impact with the CIED should be hospital-based ET),64 proving to be equally safe and effective as con- . avoided. . ventional centre-based training. . Further, people with CRT may have considerable peripheral limita-

. Downloaded from https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaa121/6119672 by guest on 21 February 2021 . tions with muscle weakness because of long-term inactivity. Thus, Two studies exposed stable, but still symptomatic HFrEF patients . with ICD (N =38)55 or CRT (N =34)52 to supervised high-intensity . when resistance training is introduced, it should be of low to moder- . ate intensity and completed twice weekly,73 highly tailored on each interval training. Exercise training was safe and exercise capacity . improved significantly in both studies. However, in CRT patients . single patient. . As example of a resistance training protocol70: (more symptomatic, NYHA III) the dropout rate was nearly 41%, . 52 . questioning the general applicability of HIIT programmes. . (1) intensity 2–3 sets with 10–12 repetitions per set at 40–70% 1 repe- In HFrEF patients with disynchrony, biventricular pacing mainly . . tition maximum (RM) with full recovery (>1 min) between sets (if improves the central component of exercise capacity. ET has the po- . 1-RM evaluation is not available, rate perception exertion of 12–15, tential to maximize the benefits from device therapy, by targeting also . Borg Scale 6–20); . the peripheral component. A 12–14 weeks supervised ET programme . (2) warm-up and cool down 10–15 min; and 53,54 . (3) at least 12 weeks duration, but preferably more. further improved peak VO2 by 16–24%, compared to CRT alone. . The majority of exercise interventions contained an aerobic com- . . Cardiac implantable electronic device recipients may experience ponent in the form of walking, cycling, running, or a combination; re- . deviations in cardiovascular risk factors (obesity, hypertension, dysli- sistance or strength training was also used in a population of ICD . . pidaemia, and diabetes). In this case, further refinement of exercise recipients, implementing 15–20-min sessions once to twice per . prescription can be recommended, within the above-mentioned 49–60 . week. Training volumes were not reported in >50% of the stud- . safety margins, and based on current evidence3; to facilitate this pro- ies and are difficult to quantify, but most were prescribed to progres- . 74 . cess, digital decision support systems are available. sively increase workloads over 2–3 months, as tolerated and the . 49–60 . interventions were implemented in outpatient CR settings. . Training programmes varied in session frequency (3–5 per week), . . session duration (30–90 min), and intensity (50–90% of peak VO2 or . 49–60 . Summary box 4 maximal HR). In a review including 1889 patients, 834 of them . . • with an ICD, the duration of CR programmes ranged from 4 to . Implantable cardioverter-defibrillator patients, following ex- 12 weeks.65 . ercise-based CR, achieved a better exercise capacity. The im- . Some studies used multicomponent interventions (support group, . pact on all-cause mortality, serious adverse events, and education, and psychological interventions).66–68 The control condi- . health-related QoL remained unclear. . • tion was represented as ‘usual care’ or no exercise recommendation. . In small studies, telemonitored ET in HFrEF was used in one . study with ICD patients and in another with CRT-D patients, Clinically meaningful effects were found between groups in peak . . proving to be equally safe and effective as conventional VO , general health, and mental health in favour of the rehabilitation . 2 . centre-based training. group, with a reduction in total attributable direct costs. . • Two studies exposed stable, but still symptomatic HFrEF 69 . One study reported a yoga intervention in the ICD population. . patients with ICD or CRT to supervised high-intensity inter- . Forty-six participants were randomized to a control group or an 8- . val training. ET was safe and exercise capacity improved sig- week adapted yoga group. Total shock anxiety decreased for the . nificantly in both studies. However, the dropout rate was . nearly high, questioning the general applicability of high-inten- yoga group and increased for the control group. Compared to the . control, the yoga group had greater overall self-compassion and . sity interval training. . • greater mindfulness. Exploratory analyses utilizing a linear model . Exercise prescription may include both endurance and resist- . ance training. Inspiratory exercise can be particularly valuable revealed that the yoga group had a 32% lower risk of experiencing . . in most fragile and recently stabilized patients. Endurance device-related firings at end of follow-up. . . training may use continuous and/or interval or intermittent Therefore, based on the knowledge of ET for HF patients, exercise . training models, 3–5 days/week, during 30–60 min, associated prescription may include both endurance and resistance training.70 . . with dynamic exercises. For continuous aerobic training, pre- Inspiratory exercise can be particularly valuable in most fragile and re- . scription may be similar to that used in HF patients, keeping 71 . cently stabilized patients. Endurance training may use continuous . in mind upper limits of the device. and/or interval or intermittent training models, 3–5 days/week, during . • Resistance training sessions (2–3 sessions/week) may . be tailored according to a preliminary evaluation of 30–60 min, associated with dynamic exercises. Continuous aerobic . training prescription may be similar to that used in HF patients,3 . strength, but special attention is required with shoulder . movement in order to avoid important strain in the side of keeping in mind upper limits of the device. . . implant, particularly in the early phase after device Resistance training sessions (2–3 sessions/week) may be tailored . . placement. according to a preliminary evaluation of strength, but special . 8 R.F.E. Pedretti et al.

. rate-adaptive SAV delay (e.g. shortest 100 ms at UTL) and a rate- Appropriate programming of . . adaptive PVARP (e.g. shortest 250 ms at UTL: this allows 1:1 conduc- cardiac implantable electronic . tion up to 350 ms = 171 b.p.m.). . device during a cardiac . Considerations on UTL and 2:1 block are particularly important in . rehabilitation programme . patients with CRT. If 1:1 tracking is not ensured, resynchronization . may be interrupted. This potentially causes non-response to CRT. If . As shown in Table 1, during CR, some challenges for patients with a . patients develop angina during exercise, the HR at the onset of angina CIED may arise. . should be recorded and the UTL should be reduced in patients with . Downloaded from https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaa121/6119672 by guest on 21 February 2021 Chronotropic incompetence is the patient lack of increased HR . AV block, typically to 110 b.p.m. in dual-chamber devices and 130 75 . and it may limit exercise tolerance. The reason for this phenom- . b.p.m. in CRT. enon may reside in the sinus node, AV node, or a pacing response. . During exercise, biological signals, such as the P wave, demon- . Therefore, rate-adaptive pacing should be programmed ‘ON’. . strate a shift in frequency content and depending on the filters of the Specific attention should be payed to potential insufficient or exag- . device may be sensed at lower amplitudes. Therefore, the P-wave . gerated sensor response to exercise, prompting reprogramming of . amplitude should be checked during exercise and atrial sensitivity . should be adjusted if necessary (e.g. 0.1–0.25 mV). Physical activity the sensor (more or less reactive, see Table 4). . In patients with AV block, the UTL should be programmed higher . can cause myopotential oversensing of the pectoral muscle (only in . than the maximum sinus rate to maintain 1:1 conduction during . unipolar sensing) or the diaphragm in ICDs with integrated bipolar (higher-level) exercise. The UTL should be lower than the HR at 2:1 . sensing.76,77 It should be checked if sensing is programmed to bipolar . block which depends on the total atrial refractory period (TARP), . in PMs and if ventricular oversensing occurs during exercise or deep equalling programmed sensed AV (SAV) delay plus the post- . respiration (or coughing) in ICDs with integrated bipolar sensing. . ventricular atrial refractory period (PVARP): TARP = SAV þ PVARP. . Rarely, electrical devices used in CR can cause oversensing. For example, if SAV is 200 ms and PVARP 300 ms, TARP equals . Transcutaneous electrical neuromuscular stimulation (TENS) and . 500 ms, so that sinus rhythm >120 b.p.m. in patients with complete . other electrical or magnetic resources should be avoided. heart block will result in a 2:1 block with a sudden drop in HR from . Exercise may trigger premature beats and tachyarrhythmias. To . 120 to 60 b.p.m. during exercise, independent of the programmed . terminate endless loop tachycardia after ventricular or supraventricu- UTL. Tracking of high sinus rates can be facilitated by programming a . lar premature beats, algorithms (usually called ‘PM mediated

Table 4 Challenges for patients with a cardiac implantable electronic device during a CR programme

Problem Programming solution ...... Chronotropic incompetence Activate sensor Insufficient heart rate increase despite sensor Increase sensor reactivity (threshold of activity detection, rate increase, duration of rate increase, etc.) Excessive pacing rate increase Decrease sensor reactivity (threshold of activity detection, rate increase, duration of rate increase, etc.) Sinus rate above the upper tracking limit Increase upper tracking limit 2:1 block during exercise Shorten sensed AV delay and/or PVARP, consider rate-adaptive AV delay and rate- adaptive PVARP Angina pectoris during exercise Limit upper tracking rate to 110 b.p.m. in patients with coronary artery disease Undersensing during exercise Increase sensitivity (atrium: up to 0.1–0.2 mV) Oversensing during exercise Check sensing polarity (bipolar!), reduce sensitivity in pacemakers, avoid TENS Multiple supraventricular or ventricular premature beats, Activate ‘PMT intervention’ in dual-chamber and CRT devices, activate ‘PVC reaction’ endless loop tachycardia in dual-chamber devices, in individual cases increase the lower rate limit Non-sustained ventricular tachycardia Prolong tachycardia detection in ICDs (>_ 40 intervals) Supraventricular tachycardia during CR Prolong tachycardia detection in ICDs (>_ 40 intervals in VT zones, >_30/40 intervals in VF zone), activate enhanced detection criteria or VT/SVT discrimination criteria, in individual patients increase tachycardia detection rate (e.g. to 200 b.p.m.) with a monitoring zone (e.g. 180–200 b.p.m.) Accelerated junctional rhythm during exercise Increase the lower rate limit in dual-chamber and CRT devices (e.g. to 70 b.p.m.), ac- tivate overdrive algorithms Shortening of intrinsic AV delay In CRT: Shorten the sensed AV delay or (better) activate rate-adaptive AV delay; if available activate negative AV hysteresis

AV, atrioventricular; CR, cardiac rehabilitation; CRT, cardiac resynchronization therapy; ICD, implantable cardiac-defibrillator; PMT, pacemaker tachycardia; PVARP, post-ven- tricular atrial refractory period; PVC, premature ventricular complex; SVT, supraventricular tachycardia; TENS, transcutaneous electrical nerve stimulation; VF, ventricular fibril- lation; VT, ventricular tachycardia. Cardiac Rehab in cardiac implantable electronic devices recipients 9

. tachycardia intervention’) should be activated in dual-chamber and . Physical activity, sports . CRT devices. Algorithms that start a long PVARP or force atrial pacing . after a premature ventricular beat [(PVC) reaction] should be acti- . counselling, and sexual activity . vated at least in dual-chamber devices. In CRT, PVC reaction algo- . General recommendations for physical activity are consistent with . rithms should rather not be activated since the associated long . the underlying pathology, such as HF, dilated cardiomyopathy, and PVARP may stop atrial triggering and interrupt CRT. Non-sustained . arrhythmogenic cardiomyopathy.79 . VT and supraventricular tachycardias during CR should not trigger . Physical activity was associated with a decreased risk of cardiac ICD therapies. To avoid unnecessary or inappropriate ICD therapy, . . events: it is considered safe and is applicable in all stable individuals, Downloaded from https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaa121/6119672 by guest on 21 February 2021 . tachycardia detection should be programmed to long values (e.g. >_ . including cardiac patients, who are on optimal medical therapy, re- 78 . gardless of the LVEF value.47 30/40 intervals in the VF, >40 intervals in the VT zone). Algorithms . for discrimination of ventricular and supraventricular tachycardia . Thus, all asymptomatic patients, regardless of the LVEF, without . should be activated. The use of very high tachycardia detection zones . exercise-induced ventricular arrhythmias should be advised to par- (e.g. >_ 200 b.p.m.) can be used on an individual basis if the risk of VT . ticipate in low to moderate intensity leisure-time exercise activities. . <200 b.p.m. is low. In this case, a monitoring zone without ICD thera- . Instead, symptomatic individuals for exercise-induced arrhythmias . should abstain from competitive and leisure sports or recreational pies should be programmed to make sure those tachycardias below . 200 b.p.m. which may cause symptoms, such as dizziness during CR . exercise associated with moderate or high exercise intensity. . In arrhythmogenic cardiomyopathy, regular exercise programmes are detected. . Accelerated junctional rhythms can occur during CR, particularly . may be associated with acceleration of the disease process and wor- . sen outcomes.80 Reducing exercise intensity was associated with a in HF. This terminates AV synchrony in dual-chamber devices and . also ventricular resynchronization in CRT. In these patients, the . substantial decrease in the risk of ventricular tachyarrhythmias or . death, to the same level as inactive patients. Therefore, while regular lower rate limit should be increased (e.g. 70 b.p.m.) and overdrive . . low-moderate intensity physical activity, i.e. the usually recom- algorithms (e.g. atrial preventive pacing) should be activated. . . mended 150 min weekly, should be considered in all patients, high- High adrenergic tone during CR can shorten intrinsic AV conduc- . . intensity exercises should be denied in this clinical condition. tion and thus interrupt CRT. To avoid this, a shorter or (better) rate- . . In patients with hypertrophic cardiomyopathy, the risk of exercise- responsive AV delay, and a negative AV hysteresis (automatic short- . . induced ischaemia should be considered.81,82 A recent study found ening of the AV delay upon ventricular sensing) can be programmed. . . that 50% of patients with hypertrophic cardiomyopathy experienced . myocardial ischaemia at rest.83 Ischaemic events were confirmed by . . positive results from high-sensitivity troponin tests. Therefore, . patients with hypertrophic cardiomyopathy should be monitored as Summary box 5 . . regard of high-sensitivity troponin positivity or negativity for safety • . 81 In case of chronotropic incompetence, rate-adaptive pacing . exercise. should be programmed ‘ON’. . For all patients with CIEDs, physical activities associated with a risk • . In patients with AV block, the UTL should be programmed . of chest trauma (e.g. rugby, boxing, martial arts) should be avoided. higher than the maximum sinus rate to maintain 1:1 conduc- . . Other sports (like soccer, basketball, baseball) can be possible while tion during (higher-level) exercise; the UTL should be lower . than the HR at 2:1 block. . wearing appropriate padding. It is noteworthy that sports with pro- • Considerations on UTL and 2:1 block are particularly import- . nounced arm movements (such as volleyball, basketball, tennis, golf, . ant in patients with CRT. If 1:1 tracking is not ensured, . climbing) may increase the risk for late lead damage due to subclavian resynchronization may be interrupted. . crush (with insulation or conductor failure). Implantation on the • . Physical activity can cause myopotential oversensing of the . contralateral side of the dominant arm (e.g. at the left side in a right- pectoral muscle (only in unipolar sensing) or the diaphragm . handed tennis player), fixation within the pocket, or submuscular in ICDs with integrated bipolar sensing. It should be checked . . placement, may improve durability of the system. It is not known if sensing is programmed to bipolar in PMs and if ventricular . whether subcostal or epicardial implant techniques provide long- oversensing occurs during exercise or deep respiration (or . . term benefit. coughing) in ICDs with integrated bipolar sensing. . . Electromagnetic interference (EMI) is unlikely with modern devi- • Rarely, electrical devices used in CR can cause oversensing, . TENS, and other electrical or magnetic resources should be . ces and no cases have been reported, however, it should always be . suspected and evaluated in specific athletic environments with elec- avoided. . • Non-sustained VT and supraventricular tachycardias during . tronic equipment (e.g. fencing). As discussed in other sections of this . CR should not trigger ICD therapies. To avoid unnecessary . paper, myopotential inhibition may result in inhibition of pacing, a or inappropriate ICD therapy, tachycardia detection should . problem that is more common with unipolar electrodes, although it be programmed to long values (e.g. >_30/40intervalsinthe . . usually can be corrected with appropriate reprogramming of the VF, > 40 intervals in the VT zone). . device. • . Algorithms for discrimination of ventricular and supraventric- . The patients must be aware of the programmed detection rate ular tachycardia should be activated. The use of very high . . cut-offs, avoiding to reach them during exercise. Conversely, detec- tachycardia detection zones (e.g. >_ 200 b.p.m.) can be used . on an individual basis if the risk of VT <200 b.p.m. is low. . tion zones need to be programmed sufficiently high to allow for high . (enough) HRs during the desired exercise levels. This practice proved 10 R.F.E. Pedretti et al.

. safe and reduced the occurrence of shocks in the ICD Sports Safety . awareness and acceptance of the disease, provision of psychological Database.84 The most common cause of inappropriate shocks in ICD . support to the patients and their caregivers, promotion of adherence . patients is the occurrence of sinus tachycardia and supraventricular . and of disease management, activation of positive affectivity and of arrhythmias.85 . personal/sociofamilial resources.89 In addition, assessment of occupa- . Underlying heart disease and endurance sports ‘per se’ carries a . tional problems, reduction in occupational distress, family and social higher risk for developing atrial fibrillation. Implantation of a dual sys- . reintegration may be included among objectives.89 . tem ICD for the sole reason of atrial arrhythmia detection and dis- . Pacemaker implantation for conventional reasons induces a crimination is generally not warranted because usually not effective.86 . clear improvement in QoL not only at several months or 1 year . Downloaded from https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaa121/6119672 by guest on 21 February 2021 Similar to other cardiovascular patients, ICD patients often experi- . after implantation but also after long-term follow-up (7.5-year ence fear about the perceived strain of sexual activity on the heart . follow-up period) as shown in 881 bradycardia PM recipients . and the subsequent potential for ICD shock. However, the absolute . included in the large scale nationwide Dutch FOLLOWPACE risk caused by sexual activity is considered to be extremely low, be- . 90 . study. cause sex for most patients represents only a moderate stress on the . Quality of life is preserved for ICD patients, comparable to PM 87 . heart. A specific and dedicated counselling has been advocated to . recipients,91 however, ICD shocks lead to psychological distress.92 88 . face this issue. . Moreover, there is discordance between patients and clinicians on in- . . formation requirements, in particular, the potential consequences of . implantation on psychological well-being and QoL in the short and Summary box 6 . . long term, as well as the care pathway at which to discuss ICD • . deactivation.93 Asymptomatic patients, regardless of the LVEF, without ex- . ercise-induced ventricular arrhythmias should be advised to . Data on perceptions, experience, and QoL of patients living with participate in low to moderate intensity leisure-time exercise . ICDs are controversial. In a systematic review, 5 randomized con- . activities. . trolled trials with a total of 5138 patients and 10 observational studies . 94 • Symptomatic patients for exercise-induced arrhythmias . with a total of 1513 patients were analysed. Patients were should abstain from competitive and leisure sports or recre- . implanted for primary prevention purposes in three studies, second- . ational exercise associated with moderate or high exercise . ary prevention in four, primary and secondary prevention in one, in intensity. . the remaining studies indications were not reported. Nine studies • In arrhythmogenic cardiomyopathy, regular exercise pro- . . found comparable QoL for ICD recipients and patients in the control grammes may be associated with acceleration of the disease . process and worsen outcomes. . groups, three studies found an increased QoL for ICD patients, and • . three studies found a decreased QoL for ICD patients.94 For all patients with CIEDs, physical activities associated with . a risk of chest trauma (e.g. rugby, boxing, martial arts) should . Controversial results were found also comparing QoL of ICD be avoided. Other sports (like soccer, basketball, baseball) . patients with that of distinct control groups: medical treatment in six, . can be possible while wearing appropriate padding. It is note- . PM in five, other typical cardiac procedures in the remaining stud- worthy that sports with pronounced arm movements (vol- . ies.94 Nevertheless, lower QoL was apparent among ICD patients leyball, basketball, tennis, golf, climbing) may increase the risk . . who experienced device discharges, with a possible relation with the for late lead damage due to subclavian crush. . number of received shocks and the time from shock.94 Number of • . The absolute risk caused by sexual activity is considered to . received shocks seems to be an important variable: MADIT-RIT be extremely low, because sex for most patients represents . . included 1500 patients from 98 hospital centres who received an only a moderate stress on the heart. A specific and dedicated . . ICD with or without concomitant CRT for primary prevention.95 In counselling has been advocated to face this issue in patients . . this study, >_2 appropriate or inappropriate ICD shocks and >_2 ap- with CIEDs. . . propriate ATPs were associated with more anxiety at 9-month . follow-up despite no significant changes in the assessment of global . . QoL by the EQ-5D questionnaire.95 . . Although it is not clear if QoL of ICD recipients is worse than . that of cardiac patients without an ICD, a proportion of them may . . suffer of anxiety and depression, like other patients with heart Psychological support and . disease. . education . Data from the Cross-Sectional National CopenHeartICD Survey . showed that patients with primary prevention ICD had lower levels . Psychosocial management directed by a psychologist is one of the . of perceived health, QoL, and more fatigue. Anxiety, poor perceived 1 . 96 core components of comprehensive secondary prevention and CR, . health, fatigue, and low QoL were all predictors of mortality. assessment and intervention modalities are described elsewhere.89 . All adults listed in the Swedish ICD and PM Registry in 2012, with . Specific objectives are identification and correction of psychosocial . an ICD implanted for at least 1 year (2658), were included in a study and/or behavioural risk factors, optimization of the patient’s . about multi-morbidity burden, psychological distress, and QoL.97 Of Cardiac Rehab in cardiac implantable electronic devices recipients 11 them, 8.5% showed depressive and 15.9% anxiety symptoms, 16.6% . 97 . Summary box 7 had type D personality. Greater multi-morbidity burden, female . sex, not working outside the home, history of ICD shocks, negative . • . Pacemaker implantation for conventional reasons induces a ICD experience, higher levels of ICD-related concerns, and the pres- . clear improvement in QoL. Quality of life is preserved for ence of anxiety, depression, or Type D personality were associated . ICD patients, comparable to PM recipients, however, ICD . with worse QoL in ICD recipients. Multi-morbidity burden and . shocks lead to psychological distress. 97 . psychological distress are essential factors related to QoL. This . • Lower QoL was apparent among ICD patients who experi- issue should be discussed with potential ICD recipients prior to . enced device discharges, with a possible relation with the

. Downloaded from https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaa121/6119672 by guest on 21 February 2021 97 . implant. . number of received shocks and the time from shock. Adjustment to life with an ICD may be challenging not only for . Although it is not clear if QoL of ICD recipients is worse than . that of cardiac patients without an ICD, a proportion of them some patients but also for their partners, with disease and individ- . 98 . may suffer of anxiety and depression. ual characteristics likely influencing the process. A cohort of 286 . • . Adjustment to life with an ICD may be challenging not only consecutively implanted patients, 21% women, and their partners . for some patients but also for their partners. completed questionnaires on social support and symptoms of anx- . • Cognitive behavioural therapy is an effective tool in managing . iety and depression, prior to ICD implantation and 12 months . stress and symptoms related to anxiety, as well as for the later.98 Higher ratings of perceived social support prior to ICD im- . minimization of catastrophic thoughts related to depressive . plantation were associated with greater reductions in couples’ . symptoms in patients with ICDs. symptoms of anxiety and depression, whereas having received an . • Elderly individuals are increasingly represented among 98 . patients with ICDs, but data describing life with an ICD are ICD shock was associated with less improvement. Secondary . prevention indication for ICD implantation and symptomatic HF . scarce among octo- and non-agenarians. Few studies have . reported elderly patients’ perspective on discussions con- were associated with less improvement in anxiety symptoms and . . cerning what shock deactivation involves, preferences on these associations applied to both patients’ and partners’ levels of . . battery replacement, and their attitudes about turning off the distress.98 . . ICD nearing end-of-life. Cognitive behavioural therapy (CBT) is an effective tool in manag- . ing stress and symptoms related to anxiety, as well as for the mini- . . mization of catastrophic thoughts related to depressive symptoms in . 99 . patients with ICDs. An integrative review indicated that CBT has . . ICD treatment in the end-of-life were evident, which may result in been effective in the treatment of ICD patients with depressive and . a potentially painful end-of-death with the ICD not being . anxiety symptoms. Research also showed that young women repre- . deactivated. sented a risk group.99 Lewin et al.38 evaluated a brief home-based . . CBT rehabilitation programme for patients undergoing implantation . of an ICD in a prospective multicentre, intention-to-treat, cluster- . External electrotherapy in cardiac . randomized controlled trial recruiting 192 patients. At 6 months, the . implantable electronic device intervention significantly improved QoL, reduced the incidence of . . clinically significant psychological distress, and significantly reduced . recipients during cardiac 38 . unplanned readmissions. . rehabilitation Finally, elderly individuals are increasingly represented among . . patients with ICDs, but data describing life with an ICD are scarce . The term external electrotherapy (electrostimulation) describes the among octo- and non-agenarians. Moreover, few studies have . medical application of electric current generated by a special electro- . reported elderly patients’ perspective on discussions concerning . therapy device and supplied to the patient via electrodes or via water what shock deactivation involves, preferences on battery replace- . . as a guide medium. Electrotherapeutic procedures may be used for ment, and their attitudes about turning off the ICD nearing end- . . improvement of circulation, reduction of tissue swelling, warming of of-life. In a survey, participants were identified via the Swedish . skin and deeper tissue layers, regulation of muscle tone, and pain . PM- and ICD-registry, with 229 octo- and non-agenarians . reduction. (82.0 ± 2.2 years, 12% female).100 About one-third (34%) had dis- . Electrotherapeutic applications are associated with the risk of elec- . cussed their illness trajectory with their physician, with those . tromagnetic interaction between the ICD or PM and the current- octo- and non-agenarians being more decisive about a future de- . applying device (EMI).101–103 The effect on implantable devices is 100 . activation (67% vs. 43%, P < 0.01). A minority (13%) had dis- . complex and not surely predictable (temporary false inhibition/trig- cussed what turning off shocks would involve with their physician, . gering, switching to asynchronous pacing rate, inappropriate energy . and just 7% had told their family their wishes about a possible de- . delivery, programme restart, and complete destruction of activation in the future.100 Therefore, a significant majority of . electronics). . patients have not discussed possible future deactivation with their . Electromagnetic interference is frequently encountered in electro- physician or family. Misunderstandings regarding withdrawing the . surgery, magnetic resonance imaging, or personal electromagnetic 12 R.F.E. Pedretti et al. equipment,104–107 but has also been described in the physiotherapeu- . underlying arrhythmias status), abstain from electrotherapy and 107–110 . tic environment. . use manual therapeutic procedures. The data situation regarding the optimal management of CIED . . Except for the safe application of ultrasound, all types of electrosti- patients in CR needing electrotherapeutic procedures is currently . . mulation are limited or contraindicated and should be performed still insufficient. Until now, there are no European guidelines or . . under continuous ECG monitoring if necessary (Table 5). recommendations regarding the use of electrotherapeutic proce- . . Particularly the use of transcutaneous electrical nerve stimulation, dures in CR. Australia is the only country with definite guidelines . . diathermy, and interference current therapy usually regarded as con- for clinical use of electro-physical agents.111 Available data are .

. traindicated in CIED patients, and should be avoided within 3 months Downloaded from https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaa121/6119672 by guest on 21 February 2021 predominantly represented as case reports. More systematically, . . of electrode implantation.113 Digby et al.112 performed a comprehensive review of the litera- . . ture based on an own 2-year retrospective analysis including all . physiotherapeutic treatments in a local physiotherapy practice fa- . . Return to work and fitness to cility. However, international physiotherapy societies and CIED . . drive manufacturers have not yet agreed on a consistent . recommendation. . . For patients with CIED, special barriers may arise in occupational re- In the management of CIED patients, the following points should . . integration, especially in industrial professions. Exposure to electrical be considered during CR: . . fields are associated with the risk of electromagnetic interaction be- . • avoid electrotherapeutic applications with high risk of EMI; . tween CIED and the EMI by superimposing intrinsic biosignals or . 105,114 • consult with the implanting centre in case of doubt; . inputting noise signals. The effect on implantable devices is • provide a magnet for deactivating the anti-tachycardia function of . . complex and not surely predictable. External fields may influence an ICD in the context of a malfunction and ensure asynchronous . electrical circuit, the internal memory or the leads/CIED case and stimulation; . . surrounding tissue, inducing various malfunctions (thermal damage, • be especially cautious in stimulation-dependent and freshly oper- . . electrode dislocation, temporary false inhibition/triggering, switching ated patients; . • interrogate the device after application of electrotherapy with pos- . to asynchronous pacing rate, inappropriate energy delivery, pro- . gramme restart, and complete destruction of electronics).115 sible interaction; and . • in case of inadequate infrastructure of the rehabilitation clinic (no . Given a risk of EMI, the implantation of CIED may be a contraindi- options of CIED programming, insufficient information about the . cation for the resumption of work in certain areas.116

Table 5 Application limitations of physiotherapeutic procedures in patients with cardiac implantable electronic devices101,111,112

Type of electrotherapy Recommendation ...... DC application Constant DC Stable galvanization 1-, 2-, 3-, or 4 cells-bath Stangerbad Out of the CIED/electrode field no restrictions (full hydrogalvanic bath) Iontophoresis Pulsed DC (constant DC þ low frequency AC) Impulse galvanization Should be avoided Diadynamic currents Should be avoided AC application High-frequency therapy (over 100 kHz) Shortwave diathermy Should be avoided Decimeter wave At extremities possible with ECG monitoring, otherwise should be avoided Microwave At extremities and head possible, At thoracal and lumbal with ECG monitoring possible Ultrasound No restrictions Medium frequency therapy (2000–36 000 Hz) Interference current Should be avoided Low-frequency therapy (up to 1000 Hz) TENS Should be avoided Stimulation current Stimulation at extremities and head possible, at thoracal and lumbal area should be avoided

CIED, cardiac implantable electrical device; ECG, electrocardiogram; TENS, transcutaneous electrical nerve stimulation. Cardiac Rehab in cardiac implantable electronic devices recipients 13

ELECTROMAGNETIC interference can be expected especially by . professional association or the Technical Control Board, and oversensing of the electric field at an AC frequency of 50/60 Hz, less . should be coordinated with the representative of the ICD 117 . covered from band filters for lower and higher frequencies. The . manufacturer; and extent and likelihood for EMI depends on exposure-related parame- . • during or at the end of a CR programme, sometimes patients . can ask information about their fitness to drive. An EHRA ters (distances from the EMI source, modulation, magnetic and elec- . tric field strengths, current frequency) and on CIED- and lead-related . Task Force on ‘ICD and driving’ was formed in 2009 to assess . the risk of driving for ICD patients based on the literature parameters (aggregate model, programming parameters, lead config- . . available. The reader is referred to the reading of this docu- uration, implantation site).118 . . ment to get an overview of the problem. Downloaded from https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaa121/6119672 by guest on 21 February 2021 The actual incidence of relevant malfunctions of the CIED due to . electromagnetic fields is low (0.5%),119 affecting high-risk individuals . . and persons who handle dangerous or heavy machines or who work in an industrial environment and it may be lower for work- . . substances. ers in non-industrial environment. If there is uncertainty about elec- . . trical, magnetic, or electromagnetic interferences, an exact . workplace analysis must be performed to identify potential risks. This . Summary . should be done by the technical personnel of the organization, the . professional association or the Technical Control Board, based on . . • Cardiac rehabilitation is a multidisciplinary intervention including field measurements, and should be coordinated with the representa- . . patient assessment and medical actions to promote stabilization, 120,121 . tive of the ICD manufacturer. . management of cardiovascular risk factors, vocational support, psy- During or at the end of a CR programme, sometimes patients can . . chosocial management, physical activity counselling, and prescrip- ask information about their fitness to drive. It is important to empha- . tion of ET. size that patients with an ICD have an ongoing risk of sudden incap- . • Millions of people with CIEDs live in Europe and their numbers . acitation that might cause harm to others while driving a car. . are progressively increasing, therefore large subsets of patients An EHRA Task Force on ‘ICD and driving’ was formed in 2009 to . admitted in CR facilities have a CIED. Cardiac rehabilitation is a . assess the risk of driving for ICD patients based on the literature avail- . unique opportunity, not only to optimize medical treatment, in- able and it remains the most recent European scientific document . crease exercise capacity, and improve patient physical and mental . condition but also to supervise the correct functioning of the de- about this argument.122 The reader is referred to the reading of this . . vice and to reassure the patient with the CIED about physical ac- document to get an overview of the problem, taking into account . . tivity. These patients should receive special attention, as their that driving restrictions vary across different countries in Europe, . . needs may differ from other patients participating in CR. Clinical have many medico legal considerations, and that this argument is au- . and technical evaluation is the first step in evaluating CIED patients thority of individual member states in Europe. The same considera- . in a CR setting. History and clinical examination, chest X-ray, . tions apply to high-risk workers, such as pilots, professional drivers, . echocardiogram, Holter monitoring, and CPET should be per- . formed before starting exercise-based CR. . • . As the basis for exercise advice and prescription, a symptom- Summary box 8 . limited exercise test, preferably CPET, is mandatory. Endurance . training intensity zones can be determined on the ventilatory • Electrotherapeutic applications are associated with the risk . . thresholds, peak VO2, or, in absence of a CPET, on HR and HR of EMI between the ICD or PM and the current-applying de- . . reserve. vice. For patients with CIED, special barriers may arise in oc- . • Both the patient and the CR team need to be aware of device set- cupational reintegration, especially in industrial professions. . . tings, especially the rate cut-off for therapy in patients with a defib- Exposure to electrical fields is associated with the risk of EMI . rillator. Patients should be instructed to keep the HR at least 10– by superimposing intrinsic biosignals or inputting noise . . 20 b.p.m. below the rate cut-off during exercise. The communica- signals. . tion of the settings to the CR team is also essential. • . In the management of the EMI risk in case of electrothera- . • Regarding effects of ET on functional capacity in CIED recipients, peutic applications during CR or EMI risk in the workplace: . most of the information relates to ICD patients, few data are avail- • avoid electrotherapeutic applications with high risk of EMI, . . able in patients with CRT. Exercise training seems to be safe, consult with the implanting centre in case of doubt; . improves aerobic capacity and is not associated with a significant • provide a magnet for deactivating the anti-tachycardia func- . . increased risk of ICD shocks or adverse events. As in patients tion of an ICD in the context of a malfunction and ensure . with HF, ET should be based on aerobic activity combined with asynchronous stimulation; . resistance exercise. Respiratory exercise can be also useful in • be especially cautious in stimulation-dependent and freshly . . most frail and recently stabilized patients. operated patients; . • In right ventricle arrhythmogenic cardiomyopathy, regular exercise • . interrogate the device after application of electrotherapy . programmes are associated with acceleration of the disease pro- with possible interaction; . cess and worsen outcomes. In patients with hypertrophic cardio- • in case of inadequate infrastructure of the rehabilitation clinic, . . myopathy, the risk of exercise-induced ischaemia should be abstain from electrotherapy; . considered they should be monitored as regard of high-sensitivity • in the workplace, if there is uncertainty about electrical, mag- . . troponin positivity or negativity for safety exercise. netic, or electromagnetic interferences, an exact analysis . • Similar to other cardiovascular patients, CIED patients, in particu- must be performed to identify potential risks. This should be . . lar those with an ICD, often experience fear about the perceived done by the technical personnel of the organization, the . strain of sexual activity on the heart and the subsequent potential 14 R.F.E. Pedretti et al.

. . 10. Daubert J-C, Saxon L, Adamson PB, Auricchio A, Berger RD, Beshai JF, for ICD shock. However, the absolute risk caused by sexual activ- . ity is extremely low, because sexual activity for most patients rep- . Breithard O, Brignole M, Cleland J, DeLurgio DB, Dickstein K, Exner DV, . Gold M, Grimm RA, Hayes DL, Israel C, Leclercq C, Linde C, Lindenfeld J, resents only a moderate stress on the heart. A specific and . Merkely B, Mont L, Murgatroyd F, Prinzen F, Saba SF, Shinbane JS, Singh J, dedicated counselling has been advocated to face this issue. . . Tang AS, Vardas PE, Wilkoff BL, Zamorano JL, Anand I, Blomstrom-Lundqvist • Psychosocial management is one of the core components of second- . C, Boehmer JP, Calkins H, Cazeau S, Delgado V, Estes NAM, Haines D, ary prevention and CR, QoL is a very important issue in CIED recipi- . Kusumoto F, Leyva P, Ruschitzka F, Stevenson LW, Torp-Pedersen CT, Task . Force Chairs. 2012 EHRA/HRS expert consensus statement on cardiac ents, particularly in those with an ICD. CBT may be an effective tool . . resynchronization therapy in heart failure: implant and follow-up recommen- in managing stress and symptoms related to anxiety and depression. . dations and management: a registered branch of the European Society of • . Cardiology (ESC), and the Heart Rhythm Society; and in collaboration with Electrotherapeutic procedures are sometimes used in CR and are . Downloaded from https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaa121/6119672 by guest on 21 February 2021 . associated with the risk of EMI. It is important to avoid electro- . the Heart Failure Society of America (HFSA), the American Society of therapeutic applications with high risk of EMI and consult with the . Echocardiography (ASE), the American Heart Association (AHA), the . European Association of Echocardiography (EAE) of the ESC and the Heart implanting centre in case of doubt. After application of electro- . Failure Association of the ESC (HFA). Europace 2012;14:1236–1286. . therapy, the device should be interrogated. . 11. Lane DA, Aguinaga L, Blomstro¨m-Lundqvist C, Boriani G, Dan G-A, Hills MT, • For patients with CIED, special barriers may arise in occupational . Hylek EM, LaHaye SA, Lip GYH, Lobban T, Mandrola J, McCabe PJ, Pedersen reintegration, especially in industrial professions. Exposure to elec- . SS, Pisters R, Stewart S, Wood K, Potpara TS, Gorenek B, Conti JB, Keegan R, . Power S, Hendriks J, Ritter P, Calkins H, Violi F, Hurwitz J; Document trical fields is associated with the risk of electromagnetic inter- . . Reviewers. Cardiac tachyarrhythmias and patient values and preferences for action between CIED and EMI. The same considerations apply to . their management: the European Heart Rhythm Association (EHRA) consen- . sus document endorsed by the Heart Rhythm Society (HRS), Asia Pacific high-risk workers, such as pilots, professional drivers, and persons . who handle dangerous or heavy machines or substances. . Heart Rhythm Society (APHRS), and Sociedad Latinoame. Europace 2015;17: . 1747–1769. • During or at the end of a CR programme, sometimes patients can . . 12. Sharma AD, Rizo-Patron C, Hallstrom AP, O’Neill GP, Rothbart S, Martins JB, ask information about their fitness to drive. An EHRA Task Force on . Roelke M, Steinberg JS, Greene HL. Percent right ventricular pacing predicts . ‘ICD and driving’ was formed in 2009 to assess the risk of driving for . outcomes in the DAVID trial. Heart Rhythm 2005;2:830–834. ICD patients based on the literature available. The reader is referred . 13. Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, . Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, to the reading of this document to get an overview of the problem. . Ehlert F, Freedman RA, Estes NAM, Greenspon A, Goldman L. Ventricular • . This clinical consensus document is expected to improve the im- . pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med 2002; plementation of adequate comprehensive CR in patients with . 346:1854–1862. CIEDs, fulfilling a previous gap in recommendations and providing . 14. Hayes DL, Boehmer JP, Day JD, Gilliam FR, Heidenreich PA, Seth M, Jones . PW, Saxon LA. Cardiac resynchronization therapy and the relationship of per- treatment optimization of these patients. . . cent biventricular pacing to symptoms and survival. Heart Rhythm 2011;8: . 1469–1475. . 15. Ruwald MH, Mittal S, Ruwald A-C, Aktas MK, Daubert JP, McNitt S, Al-Ahmad Conflict of interest: none declared. . . A, Jons C, Kutyifa V, Steinberg JS, Wang P, Moss AJ, Zareba W. 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